Questions & answers
The following questions & answers are intended to provide guidance and assist interested individuals and groups to understand the proposed ANZTPA regulatory scheme.
Further questions & answers will be added as they arise during the consultation process.
Phase 1
The following questions & answers represent key questions raised during the ANZTPA Phase 1 Stakeholder Consultation Sessions in June 2006. These have been divided into specific and general regulatory area topics.
- Questions & answers about the overall proposed regulatory scheme
- Questions & answers about consultation and governance and accountability arrangements
- Questions & answers about fees and charges
- Questions & answers about good manufacturing practice
- Questions & answers about regulating prescription and over-the-counter medicines
- Questions & answers about regulating complementary medicines
- Questions & answers about regulating medical devices
Phase 2
The following questions & answers represent key questions raised during the ANZTPA Phase 2 targeted focus group workshops in November 2006.
- Questions and answers about the proposed regulation of blood
- Questions and answers about the proposed arrangements for product vigilance
- Questions and answers about the proposed medicines scheduling provisions
Phase 3
The following questions & answers represent key questions raised during the ANZTPA Phase 3 targeted focus group workshops in May 2007.
- Questions and answers about In-Vitro Diagnostic Medical Devices (IVDs) as included in the draft Medical Devices Rule
- Questions and answers about the Regulation of Human Cellular and Tissue Therapies (HCTs) under ANZTPA
URL: http://www.anztpa.org/qa.htm